Doctoral Dissertation Research in Economics: The Effect of Deregulation on the Cost, Availability, and Quality of Health Care

经济学博士论文研究：放松管制对医疗保健成本、可用性和质量的影响

• 批准号: 2242324
• 负责人: Jeffrey Clemens
• 金额: $ 2.37万
• 依托单位: University of California-San Diego
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2242324&HistoricalAwards=false
• 关键词: Doctoral; Dissertation; Research; Economics; Effect

The U.S. Food and Drug Administration (FDA) regulates a wide array of health care products to ensure their safety and efficacy before they can be sold to consumers. While these regulations are intended to protect consumers, they also inevitably make it more expensive and time-intensive for companies to bring new medical technology to the market. These hurdles could leave consumers with fewer products to choose from or even delay their access to potentially life-saving medical technology. Without the threat of new entrants, existing firms are able to charge higher prices, knowing that consumers have few alternatives. Focusing on medical devices, the author(s) asks whether relaxing FDA regulation could increase the quality and accessibility of health care and combat rising costs. This project combines new data on millions of medical products with statistical analysis to understand how deregulation affects competition, prices, quantity, and quality in the market for medical devices. Specifically, the author(s) will study an FDA deregulation event in 2015 that deregulated some medical devices but not others. The results of this study will be valuable for policymakers who seek to make informed decisions about how to balance the benefits of product regulation against the costs it imposes on firms and consumers.Products regulated by the U.S. Food and Drug Administration (FDA) account for 20 cents out of every dollar Americans spend (Food and Drug Administration, 2021). On the one hand, these regulations — which often take the form of pre-market approval processes — aim to ensure the safety and efficacy of consumer products. On the other hand, pre-market approvals can impose substantial costs on manufacturers, which prevent firm entry and can even reduce product safety (Rogers, 2022). This project considers how FDA regulation interacts with market forces and the resulting effect on the cost and quality of products in an important sector: medical devices. The author(s) bring together detailed data on market entry, device transactions, and insurance claims with econometric methods to answer this question. They exploit a 2015 FDA deregulation event that removed pre-market testing for 250 medical device types as a “natural experiment” and use difference-in-difference and event study techniques to compare the effects on deregulated versus unaffected device types. They first use FDA registration data to assess the effects on market structure, like the number and types of firms that sell these devices. Next, they use fine-grained data on millions of medical device purchases made by healthcare providers to study the effects on prices and quantities of devices purchased. Finally, they use insurer claims and consider whether the prices, quantity, and quality of procedures that use these devices change. The project’s findings will provide policymakers with a better understanding of how regulation interacts with market forces and causes ripple effects throughout the supply chain in an important industry.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

美国食品和药物管理局(FDA)对一系列保健产品进行了监管，以确保它们在销售给消费者之前的安全性和有效性。虽然这些规定旨在保护消费者，但它们也不可避免地使公司将新的医疗技术推向市场的成本和时间密集度更高。这些障碍可能会让消费者有更少的产品可供选择，甚至推迟他们获得潜在的挽救生命的医疗技术。在没有新进入者的威胁下，现有的公司能够收取更高的价格，因为他们知道消费者几乎没有其他选择。作者(S)聚焦于医疗器械，询问放松FDA的监管是否可以提高医疗保健的质量和可及性，并应对不断上涨的成本。该项目将数百万种医疗产品的新数据与统计分析相结合，以了解放松管制如何影响医疗器械市场的竞争、价格、数量和质量。具体地说，作者(S)将研究2015年FDA放松监管的事件，该事件放松了一些医疗器械的监管，但没有放松其他医疗器械的监管。这项研究的结果将对政策制定者有价值，他们试图就如何在产品监管的好处与其强加给公司和消费者的成本之间做出明智的决定。美国食品和药物管理局(FDA)监管的产品占美国人每一美元支出的20美分(食品和药物管理局，2021)。一方面，这些法规--通常采取上市前审批程序的形式--旨在确保消费品的安全和功效。另一方面，上市前的批准可能会给制造商带来巨大的成本，这会阻碍企业进入市场，甚至会降低产品安全(Rogers，2022)。该项目考虑FDA的监管如何与市场力量相互作用，以及由此对医疗器械这一重要部门的产品成本和质量产生的影响。作者(S)用计量经济学方法综合了市场准入、设备交易和保险索赔的详细数据来回答这个问题。他们利用2015年FDA放松监管的一次活动，将250种医疗设备的上市前测试作为一种“自然实验”，并使用差异差异和事件研究技术来比较放松监管和未受影响的设备类型的影响。他们首先使用FDA的注册数据来评估对市场结构的影响，比如销售这些设备的公司的数量和类型。接下来，他们使用医疗保健提供者购买的数百万医疗设备的细粒度数据来研究对设备购买价格和数量的影响。最后，他们使用保险公司的索赔，并考虑使用这些设备的程序的价格、数量和质量是否发生变化。该项目的发现将使政策制定者更好地了解监管如何与市场力量相互作用，并在一个重要行业的整个供应链中造成连锁反应。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。